Indian API Manufacturer Cited for Recordkeeping Failures

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PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-08-05-2015, Volume 11, Issue 8

“Rough notes” documentation and data management failures lead to warning letter for Mahendra Chemicals.

Mahendra Chemicals, an API manufacturer in Naroda, Ahmedabad, Gujarat, India was issued a Warning Letter from FDA on July 13, 2015 for deviations for cGMPs observed during a May 19–24, 2014 inspection and the company’s subsequent insufficient corrective actions to FDA’s findings.

FDA inspectors cited the company’s failure to record activities when performed and the subsequent destruction of original records. In particular, FDA noted that batch records were completed days after operations had been completed, the company released lots before approval, failed to maintain original manufacturing records, and in some cases, backdated records. Some operators used “rough notes” or unbound loose paper to record manufacturing data and later destroyed the original records after transcription into batch production records.

In the letter, FDA stated: “Your response does not explain your use of rough notes for documenting cGMP data. This practice, in conjunction with backdating records, raises additional concerns about the integrity, authenticity, and reliability of all your data, and the quality of your APIs.”

A second observation noted the laboratory system lacked access controls to prevent raw data from being deleted or altered and employees had uncontrolled access to operating systems and data acquisition software. The warning letter noted, “There is no assurance that you maintain complete electronic raw data for your Gas Chromatography (GC) instrument. FDA investigators observed multiple copies of raw data files in the recycle bin connected to the GC instrument QC-04 even in the presence of ‘Do Not Delete Any Data’ notes posted on two laboratory workstation computer monitors.” The company’s actions to date in implementing password procedures were not satisfactory, FDA reports.


FDA noted in the letter that the company failed to train employees on their particular operations and related CGMP practices; employees stated that they had not received on-the-job training for their production operations and there was no record of training for the GC analyst testing for residual solvent release in final API.

Source: FDA